The following data is part of a premarket notification filed by Leventon, S.a. with the FDA for Dosi Flow.
| Device ID | K851058 |
| 510k Number | K851058 |
| Device Name: | DOSI FLOW |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740 |
| Contact | Juan Alfonso |
| Correspondent | Juan Alfonso LEVENTON, S.A. POLIGONO CAN SUYER, 11 SANT ANDREU DE LA BARCA Barcelona, ES 08740 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-14 |
| Decision Date | 1985-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18436020767323 | K851058 | 000 |
| 18436020767217 | K851058 | 000 |
| 18436020764254 | K851058 | 000 |
| 18436020763462 | K851058 | 000 |
| 18436020761369 | K851058 | 000 |
| 18436020760911 | K851058 | 000 |
| 18436020760560 | K851058 | 000 |
| 18436020760096 | K851058 | 000 |
| 18436020769167 | K851058 | 000 |
| 08436020767227 | K851058 | 000 |
| 18436020767231 | K851058 | 000 |
| 18436020767316 | K851058 | 000 |
| 18436020767309 | K851058 | 000 |
| 18436020767293 | K851058 | 000 |
| 18436020767286 | K851058 | 000 |
| 18436020767279 | K851058 | 000 |
| 18436020767262 | K851058 | 000 |
| 18436020767255 | K851058 | 000 |
| 08436020767241 | K851058 | 000 |
| 18436020769150 | K851058 | 000 |